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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phantom, Anthropomorphic, Radiographic
510(k) Number K840131
Device Name COMPUTED TOMOGRAPHY CALIBRATION PHANT
Applicant
Imatron, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Imatron, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1950
Classification Product Code
IXG  
Date Received01/10/1984
Decision Date 02/21/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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